The following data is part of a premarket notification filed by Capacity Sports, Llc with the FDA for Vestibular Analysis Apparatus.
| Device ID | K121590 |
| 510k Number | K121590 |
| Device Name: | VESTIBULAR ANALYSIS APPARATUS |
| Classification | Apparatus, Vestibular Analysis |
| Applicant | CAPACITY SPORTS, LLC 2800 PLEASANT HILL SUITE 175 Pleasant Hill, CA 94523 |
| Contact | Pamela M Buckman |
| Correspondent | Pamela M Buckman CAPACITY SPORTS, LLC 2800 PLEASANT HILL SUITE 175 Pleasant Hill, CA 94523 |
| Product Code | LXV |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-05-31 |
| Decision Date | 2012-09-20 |
| Summary: | summary |